Budesonide in Patients With Immune Mediated Enteropathies

Study Purpose

Researchers are trying to determine if withdrawal of budesonide therapy in patients with
immune-mediated enteropathies doing well on therapy will result in worsening symptoms,
histology, quality of life, and micronutrient/nutritional status when compared to continued
therapy.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Interventional

Eligible Ages

18 Years and Over

Gender

All

More Inclusion & Exclusion Criteria

Inclusion Criteria

- Patients will be recruited from the Division of Gastroenterology and Hepatology and
the Mayo Clinic in Rochester, MN.

- Adult patients with immune mediated enteropathies who have had improvement in symptoms
and histology on oral budesonide therapy.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

This study aims to evaluate patients with small intestinal diseases caused by the immune
system (refractory celiac disease type 1, CVID enteropathy, autoimmune enteropathy, and
collagenous enteropathy) who have had improvement in symptoms and small intestine healing
with oral budesonide.
Patients who meet inclusion criteria and agree to enter the study will be included for 12
weeks or until they choose to discontinue or there are concerns for safety.
At the beginning of the study, patients will undergo questionnaires, blood draw, urine and
stool collections, physical exam, and an upper scope (esophagogastroduodenoscopy) with
biopsies from the small intestine. They will then be randomized to either continued therapy
on their current dose and formulation of budesonide (medication provided by the study) or to
withdrawal of the medication over 2 weeks and then no medication during the study. Daily
questionnaire on symptoms will be recorded.
Patients will be assessed in the clinical research unit monthly during the study with a
questionnaire, physical exam, blood draw, and urine/stool collections.
Finally, at the end of the trial (12 weeks) or at the time of withdrawal from the trial, the
patients will complete questionnaires, physical exam, blood collection, urine/stool
collection, and upper scope (esophagogastroduodenoscopy) with small bowel biopsies.

Arms & Interventions

Arms

No Intervention: Continued Budesonide

Patients in this arm continue budesonide at the dose they were taking at the time of enrollment in the trial

Experimental: Withdrawal of Budesonide

Patients are weaned off of budesonide over 2 weeks and continued off of the medication for the duration of the trial

Interventions

Drug: - Withdrawal of Oral Budesonide

The intervention arm will taper and stop budesonide therapy (withdrawal).

Contact a Trial Team

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